Clinical trial pharmacovigilance services
Medical writing services
Personal coaching
Pharmacovigilance consultancy
Physician / medic services
PSUR writing services
Quality management consultancy
QPPV consultancy
Regulatory affairs consultancy
Signal detection consultancy
Training services
Panacea is a leading provider of pharmacovigilance, regulatory affairs, and quality services. Our flexible and responsive technical teams help our clients in a variety of ways; whether it is a one-off task, a fixed-term project or a continuous relationship.
Our services include:
Pharmacovigilance
Full and ad hoc services including:
- UK & EU QPPV services
- Local PV services (EU / worldwide)
- Risk Management Plans (RMPs)
- Periodic Safety Update Reports (PSURs)
- Case processing
- Signal detection and management
- Fully validated pharmacovigilance database
- Global literature monitoring
Regulatory Affairs
- MA applications and lifecycle management
- Product Information preparation and maintenance
- Quality Overall Summaries
- Clinical and Non-clinical Overviews
- XEVMPD maintenance
Quality
- Quality Management System (QMS) review and gap analysis
- SOP reviews, writing & implementation
- Maintenance and management of Pharmacovigilance Agreements / SDEAs
- Inspection preparations / training
- Creation and maintenance of Pharmacovigilance System Master Files (PSMFs)
- Pharmacovigilance training